Pain relieving composition

ABSTRACT

A pain relieving composition that includes an anesthetic in the range of 0.5%-7.0% by weight (“w/w”), an anti-inflammatory agent in the range of 1.0%-11.0% w/w, a moisturizing agent in the range of 0.5%-12.0% w/w, a humectant in the range of 0.5%-13.0% w/w, a penetration enhancing agent in the range of 0.5%-7.0%, and a carrier solvent in the range of 40.0%-97.0% w/w to be used before and/or after procedures which cause damage to human skin.

BACKGROUND OF THE INVENTION

The present invention is generally directed to topical pain relievingcompositions. More particularly, the present invention relates totopical pain relieving compositions used for the treatment of skinbefore and/or after the removal of human body hair, waxing (with soft orhard wax), laser hair removal, tattoo application or removal, sugaring,permanent make-up applications and/or any other procedure where theepidermis may be damaged.

Generally, during various body hair removal or laser tattoo removalprocedures, an individual will experience pain and damage to theepidermis. Procedures such as waxing and laser tattoo removal arebasically a localized control burning of the skin, which results in mildburn-like damage such as redness, mild swelling, irritation,inflammation and dryness. This pain and damage is especially unpleasantupon sensitive areas such as an individual's bikini line. Presently,topical pain relieving compositions used to alleviate pain duringprocesses such as waxing (with soft or hard wax), laser hair removal,shaving, tweezing, electrolysis and tattooing or tattoo removal,sugaring, and permanent make-up applications do not simultaneously treatskin damage.

Accordingly, there is a need for a topical pain relieving composition tobe used during processes which damage a person's skin which not onlyminimizes the pain, but soothes, heals, decreases inflammation andmoisturizes the skin as well. Such a composition should includeingredients such as an anesthetic to reduce pain, an anti-inflammatoryto sooth and heal, a moisturizing agent, a humectant, a penetrationenhancing agent, a thickener, an emollient, a solvent stabilizer, apreservative, an emulsifier, an ultraviolet absorber, a colorant, and acarrier solvent. The present invention fulfills these needs and providesfurther related advantages.

SUMMARY OF THE INVENTION

The pain reliving composition disclosed herein preferably includes ananesthetic in the range of 0.5%-7.0% by weight (“w/w”) of thecomposition, an anti-inflammatory agent in the range of 1.0%-11.0% w/wof the composition, a moisturizing agent in the range of 0.5%-12.0% w/wof the composition, a humectant in the range of 0.5%-13.0% w/w of thecomposition, a penetration enhancing agent in the range of 0.5%-7.0% w/wof the composition, and a carrier solvent in the range of 50.0%-97.0%w/w of the composition.

The anesthetic may be any combination of local anesthetics, includingbenzocaine, capsaicin, lidocaine, prilocaine, tetracaine or pramoxine.Preferably, the composition includes lidocaine, capsaicin or pramoxinein the range of 2.5%-6.0% w/w to ensure adequate numbing of theepidermis and dermis. Even more preferably, the composition includes 4%w/w of lidocaine.

The anti-inflammatory agent of the composition may include a naturalagent or a non-steroidal anti-inflammatory drug (hereinafter “NSAID”).Natural agents may include Aloe barbadensis leaf juice, Ginger rootextract, chamomile oil, grape seed extract, marigold extract, tea treeoil, lavender oil, peppermint oil or mint oil. NSAIDs may include acetylsalicylic acid, diclofenac, ibuprofen, ketoprofen or piroxicam.Preferably, the composition includes 1.5%-6.0% w/w of Aloe barbadensisleaf juice, tea tree oil, peppermint oil or diclofenac to reduceinflammation which further soothes the damaged area of skin and promoteshealing. Even more preferably, the composition includes 2.5% w/w of aloebarbadensis leaf juice which adequately soothes and heals damaged skin.

The moisturizing agent may include jojoba (simmondsia chinensis) seedoil, palm oil, coconut oil, almond oil, olive oil or castor oil.Preferably, the composition includes 0.5%-10.0% w/w of jojoba seed oil,and even more preferably, 1.0% w/w of jojoba seed oil, which enables thecomposition to provide the skin with all day moisturization.

The humectant may include hexylene glycol, propylene glycol, butyleneglycol, sorbitol or glycerin. Preferably, the composition includes0.5%-10.0% w/w of hexylene glycol or propylene glycol which attractswater and prevents the loss of moisture from the skin. Even morepreferably, the composition includes 1.0% w/w of hexylene glycol.

The penetration enhancing agent may include dimethyl sulfoxide (DMSO),ethanol, disodium ethylenediaminetetraacetic (EDTA) or lauramide DEA.Preferably, the composition includes 0.5%-5.0% w/w of DMSO in order toensure adequate penetration of the anesthetic through the cutis. Thecomposition may also preferably include 2.5% w/w of DMSO to ensureadequate skin absorption by the anesthetic.

The carrier solvent may include water or mineral oil. Preferably, thecarrier solvent includes 52.0%-94.0% w/w of water to add moisture to theskin and provide the composition with a non-greasy feel.

Additionally, the composition may include a thickener in the range of2.0%-10.0% w/w of the composition. The thickener may include cetylalcohol, xanthan gum, beheny alcohol, carbomer or hydroxypropylmethycellulose. Preferably, the composition includes 3.0%-8.0% w/w ofcetyl alcohol to provide the composition with higher viscosity. Evenmore preferably, the composition includes 6.5% w/w of cetyl alcoholgiving the composition its desired viscosity, texture and spreadability.

The composition may further include sodium polyacrylate and caprylylglycol. Preferably, the composition includes 0.5%-5.0% w/w of sodiumpolyacrylate, which provides skin conditioning properties because of itsability to hold 400-500 times its weight in water, and 0.05%-4.0% w/w ofcaprylyl glycol to further stabilize the composition. Even morepreferably, the composition includes 1.5% w/w of sodium polyacrylate and0.3% w/w of caprylyl glycol.

In addition to ingredients above, the composition may also include anemulsifier in the range of 0.5%-5.0% w/w. Preferably, the emulsifier mayinclude stearic acid or glyceryl monostearate. Even more preferably, thecomposition includes 2.5% w/w of stearic acid which provides properemulsification.

The composition may also include a preservative of potassium sorbate,phenoxyethanol, methylparaben or polyparaben. Preferably, thepreservative includes potassium sorbate in the range of 0.0005%-1.0% w/wof the composition and phenoxyethanol in the range of 0.0005%-1.0% w/w.Even more preferable, the composition includes 0.001% potassium sorbateand 0.5% w/w phenoxyethanol which would adequately inhibit microorganismdevelopment and enhance the composition's shelf-life.

Furthermore, the composition may also include an ultraviolet absorber inthe range of 0.05%-2.0% w/w of the composition and a colorant in therange of 0.05%-2.0% w/w. The ultraviolet absorber may includebenzophenone-4 or benzophenone-3 and the colorant may include any colorof dye which would not color the skin when applied. The colorantselected should also be distinct from any color emulating bodilyexudates. Preferably, the colorant includes blue 1, blue 2, blue 10 orblue 40, the ultraviolet absorber includes 0.15% of benzophenone-4 toadd sunscreen properties to the composition, and the colorant includes0.08% of blue 1 giving the composition its distinct color.

Accordingly, the topical pain relieving composition described hereincould include any combination of the above described embodiments. All ofthe above-identified ingredients could be mixed and matched depending onthe desired effect of the pain relieving composition. Preferably, thecombination of the above-identified ingredients produces a painrelieving composition that soothes, moisturizes, heals and protects theskin.

Other features and advantages of the present invention will becomeapparent from the following detailed description, when taken inconjunction with the accompanying drawings, which illustrate, by way ofexample, the principles of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The human skin is composed of two layers: (1) the outer layer called theepidermis; and (2) the layer directly underneath called the dermis.Together, the layers form what is called the cutis. The epidermis iscomposed of 5 sublayers: the stratum corneum, the stratum lucidum, thestratum spinosum and the stratum germinativum. Its main function is toprotect the body from injury and the outside environment.

The dermis, on the other hand, is the layer beneath the epidermis thatincludes connective tissue which cushions the body from stress andstrain. It is structurally divided into two areas: a superficial areaadjacent to the epidermis, called the papillary region, and a deeper andthicker area known as the reticular region. Within the dermis lie theMechanoreceptors (nerve endings) which provide the individual with theirsense of touch, as well as their sensitivity to pain and heat. Thedermis also contains the hair follicles, sweat glands, sebaceous glands,apocrine glands, lymphatic vessels and blood vessels. For hair removal,the composition preferably penetrates to the dermis to maximize numbingeffectiveness.

During hair removing procedures such as waxing (with soft or hard wax)and laser removal, the various layers of the epidermis and dermis aredamaged. These layers of the skin are essentially torn or ripped off, orin the instances of waxing and laser tattoo removal, are mildly burned,causing the individual significant pain. Afterwards individualsexperience redness, irritation, inflammation, swelling and dryness tothe treated areas. The pain relieving composition disclosed herein isused, not only for the purpose of numbing a localized area of the skinbefore any painful procedure, but may also be used afterwards to relievepain. The pain relieving cream should also heal, soothe and moisturizethe skin of any redness, irritation, swelling, inflammation or drynessthat may occur. The pain relieving composition may be used before and/orafter any of the following procedures: body hair removal with wax,shaving, tweezing, laser hair removal, tattooing or tattoo removal,sugaring, permanent make-up applications, electrolysis as well as a painreliever for sunburns.

Additionally, the cream may be used as a desensitizing agent to improvesexual performance of males suffering from premature ejaculation. Priorto sexual intercourse, a male individual may apply the cream to hispenis in order to reduce sensitivity which would allow him to prolongthe act of sexual intercourse, thus improving his performance.

Prior to any procedure that may cause damage to the epidermis and/ordermis; the user would apply the subject pain reliving cream to the skinarea before treatment in order to preemptively numb the area inanticipation of pain. For hair removal with wax, the pain relievingcomposition is applied to the skin and left for a period of timesufficient to allow the anesthetic to absorb through the epidermis andinto the dermis where the nerve endings and hair follicles reside,numbing the area before treatment. The individual will experiencenumbing effects as quickly as 10-15 minutes. Preferably, the timesufficient to allow the anesthetic to absorb into the dermis that allowsfor a maximum numbing effect is approximately 30 minutes. While the painrelieving composition is allowed to take effect, the area may optionallybe covered either with a wrapping or piece of clothing. Once theanesthetic has taken effect, any excess lotion is wiped off sufficientlypreparing the area of skin for the hair removal procedure. Once the waxis applied and pulled off, removing the hair from the skin, the painrelieving composition may be reapplied to further relieve pain as wellas to heal, soothe and moisturize the treated area.

The pain relieving composition preferably includes an anesthetic in therange of 0.5%-7.0% by weight (“w/w”) of the composition, ananti-inflammatory agent in the range of 1.0%-11.0% w/w of thecomposition, a moisturizing agent in the range of 0.5%-12.0% w/w of thecomposition, a humectant in the range of 0.5%-13.0% w/w of thecomposition, a penetration enhancing agent in the range of 0.5%-7.0% w/wof the composition, and a carrier solvent in the range of 50.0%-97.0%w/w of the composition.

The anesthetic may include benzocaine, capsaicin, lidocaine, prilocaine,tetracaine or pramoxine. Once absorbed through the epidermis and intothe dermis where the nerve endings reside, the listed anesthetics allprovide a numbing sensation and pain relieving properties by preventingthe transmission of nerve impulses. Preferably, the composition includeslidocaine, capsaicin or pramoxine in the range of 2.5%-6.0% w/w toensure adequate numbing of the area of skin to be treated. Even morepreferably, the composition includes 4% w/w of lidocaine.

The anti-inflammatory may include a natural agent, such as Aloebarbadensis leaf juice, Ginger root extract, chamomile oil, grape seedextract, marigold extract, tea tree oil, lavender oil, peppermint oil,mint oil, salvia officinalis (sage) leaf extract, chamomilla recutita(matricaria) flower extract, tocopherol or allantoin. The above listednatural agents all contain various enzymes, vitamins, and biologicallyactive compounds which provide anti-inflammatory, anti-bacterial,anti-microbial, disinfectant, analgesic (pain-killing) properties thatnot only soothe the skin after damage, but promote healing as well. Whenapplied before skin damaging procedures, they may soften the skin toease hair removal. For example, tocopherol contains vitamin E thatfunctions as an antioxidant and balances inflammation associated withthe skin. In this respect, tocopherol is suitable for healing the skin(e.g., reducing scarring after a skin injury). Allantoin works as amoisturizer to increase water content and enhance desquamation of theepidermis, it also increases skin smoothness, acts as an anti-irritant,and serves as a skin protectant. When applied afterwards, theseingredients help to heal and soothe damaged skin with theiranti-inflammatory and anti-bacterial proprieties. In one embodiment, thecomposition may include 1.0%-6.0% w/w of Aloe barbadensis leaf juice,tea tree oil or peppermint oil and more preferably includes 1.0%-4.5%w/w of Aloe barbadensis leaf juice. In an alternative embodiment, thecomposition may include 0.5%-2.5% w/w of salvia officinalis (sage) leafextract, chamomilla recutita (matricaria) flower extract, tocopherol, orallantoin. In a particularly preferred embodiment, the compositionincludes therapeutic effective amounts of salvia officinalis (sage) leafextract, chamomilla recutita (matricaria) flower extract, tocopherol,and allantoin in a combined 0.5%-2.5% w/w of the composition.

In another embodiment, the anti-inflammatory may include a non-steroidalanti-inflammatory drug (“NSAID”). Certain NSAIDs may include acetylsalicylic acid, diclofenac, ibuprofen, ketoprofen, naproxen orpiroxicam. NSAIDs are typically found in creams for relief of pain inthe treatment of arthritis or hemorrhoids. When applied topically to theskin, NSAIDs help heal and soothe damaged skin with anti-inflammatoryproperties that work by inhibiting the body's synthesis ofprostaglandins which are the messenger molecules in the process ofinflammation. Preferably, the composition includes 1.0%-6.0% w/w ofdiclofenac or ibuprofen.

The moisturizing agents may include jojoba seed oil, almond oil, palmoil, coconut oil, olive oil or castor oil. The moisturizing agent isused to treat dryness associated with skin damage. Preferably, thecomposition includes 0.5%-10.0% w/w of jojoba seed oil, and specifically1.0% w/w of jojoba seed oil. jojoba seed oil provides the skin with allday moisturization because its chemical structure is most similar to thehuman skin oil, sebum. This similarity in structure facilitates skinabsorption as well as balance oil production.

The humectant may include hexylene glycol, propylene glycol, butyleneglycol, sorbitol or glycerin. Humectants help preserve moisture or watercontent in the skin and enhances the moisturizing capabilities of thepain relieving composition disclosed herein. Preferably, the compositionincludes 0.5%-10.0% w/w of hexylene glycol which is hydrophilic meaningit attracts water and prevents the loss of moisture from the skin. Evenmore preferably, the composition includes 1.0% w/w of hexylene glycol.Alternatively, the composition includes 0.5%-10.0% w/w of glycerin, andmore specifically 1.0% w/w of glycerin.

The penetration enhancing agent includes dimethyl sulfoxide (DMSO),ethanol, disodium ethylenediaminetetraacetic (EDTA) or lauramide DEA.The penetration enhancing agent facilitates the absorption of theanesthetic into the cutis to numb the nerves. Preferably, thecomposition includes 0.5%-5.0% w/w of DMSO, and specifically 2.5% w/w ofDMSO. Before hair removal or other painful inflictions to the skin, theDMSO enhances penetration of the anesthetic into the cutis bydisordering or ‘fluidizing’ the lipid structure of the stratum corneum,the outer most layer of the epidermis. DMSO is also known to extractlipids thereby forming aqueous channels within the stratum corneum thatincrease permeability. This allows the anesthetic to be absorbed throughthe epidermis and into the dermis to block nerve transmissions, therebyreducing pain during hair removal other painful inflictions to the skin.

The carrier solvent may include water or mineral oil. For example, thecarrier solvent includes 52.0%-94.0% w/w of water to add moisture to theskin, increases spreadability properties and provide the compositionwith a non-greasy feel. In a particularly preferred embodiment, thecarrier solvent is deionized water.

Any combination of the above described ingredients could be used to makethe pain relieving composition. In an alternative embodiment, thecomposition may also include a thickener in the range of 2.0%-10.0% w/wof the composition. The thickener may include cetyl alcohol, xanthangum, behenyl alcohol, carbomer or hydroxypropyl methycellulose. Theamount of the thickener agent depends on the desired viscosity, whichdetermines the spreadability, texture and general “feel” the userexperiences when the composition is applied and absorbed into the skin.Preferably, the composition includes 3.0%-8.0% w/w of cetyl alcohol toprovide the composition with higher viscosity. More specifically, thecomposition preferably includes 6.5% w/w of cetyl alcohol to give thecomposition desired viscosity, texture and spreadability.

In yet another embodiment, the composition may further include sodiumpolyacrylate and caprylyl glycol. Preferably, the composition includes0.5%-5.0% w/w of sodium polyacrylate to provide skin conditioningproperties and 0.05%-4.0% w/w of caprylyl glycol to further stabilizethe composition. Even more preferably, the composition includes 1.5% w/wof sodium polyacrylate and 0.3% w/w of caprylyl glycol. Sodiumpolyacrylate and caprylyl glycol are both emollients which help furthersoften and moisturize the skin by reducing water loss from the epidermisand helps stabilize the composition. Sodium polyacrylate is known as awaterlock polymer capable of absorbing as much as 400-500 times its massin water and caprylyl glycol further stabilizes the composition, whileproviding moisture and skin conditioning properties.

The composition disclosed herein may further include an emulsifier inthe range of 0.5%-5.0% w/w. Preferably, the emulsifier includes stearicacid, glyceryl monostearate, polysorbate 60, or potassium cetylphosphate. Typically, the amount of emulsifier depends on the amounteffective to homogenize the composition. In one preferred embodiment,the composition includes 2.5% of stearic acid which provides properemulsification for the composition. In another embodiment, thecomposition may include 1.0%-4.5% of polysorbate 60, potassium cetylphosphate, or a combination of both. For example, polysorbate 60 can beused as an emulsifier to solubilize essential oils into water-basedproducts or lotions and potassium cetyl phosphate functions as asurfactant and emulsifying agent used as a cleansing agent (like adetergent).

In another embodiment, the composition may also include a preservativein the range of 0.0005%-1.0%. The preservative may include potassiumsorbate, phenoxyethanol, methylparaben, polyparaben, ethylhexylglycerin,sodium hydroxide, BHT, or tetrasodium EDTA. Preferably, the preservativeincludes potassium sorbate in the range of 0.0005%-1.0% w/w of thecomposition and phenoxyethanol in the range of 0.0005%-1.0% w/w.Alternatively, the composition may include 0.001% w/w potassium sorbateand 0.5% w/w phenoxyethanol which would adequately inhibit microorganismdevelopment and enhance the composition's shelf-life. In anotherpreferred embodiment, the composition includes at least one ofethylhexylglycerin, sodium hydroxide, BHT, or tetrasodium EDTA in therange of 0.0005%-1.0% w/w. In fact, the composition may include variouscombinations of multiple preservatives, but it is preferred that theaggregate w/w of all preservatives in the composition do not exceed 1.0%w/w of the composition. In particular, ethylhexylglycerin provides skinconditioning and sodium hydroxide acts as a cleaning agent to dissolveprotein-based skin deposits.

In an additional embodiment, the composition may also include anultraviolet absorber in the range of 0.05%-2.0% w/w of the compositionand a colorant in the range of 0.05%-2.0% w/w. The ultraviolet absorbermay include benzophenone-4 or benzophenone-3 and the colorant mayinclude any desired color of dye safe for use upon the skin. Forexample, the colorant may include white, yellow, blue (e.g., blue 1,blue 2, blue 10 or blue 40), green, red, orange or violet. Preferablythe dye chosen would not color the skin after the cream is applied. Theultraviolet absorber may include 0.15% of benzophenone-4 to addsunscreen properties to the composition and the colorant may include0.08% of blue 1 to give the composition a distinct color.

In yet another embodiment, the pain relieving composition may include anemollient in the range of 1.00%-15.00% w/w of the composition. Specificemollients may include C12-15 alkyl benzoate, cetearyl alcohol,isopropyl palmitate, cyclopentasiloxane, cucumis sativus (cucumber)fruit extract, or glycol distearate. In particular, C12-15 alkylbenzoate has other purposes, in addition to being an emollient, such asreducing the greasiness of other oils in the composition, functioning asan anti-tackiness agent, lubricant, binder and wetting agent formineral-based ingredients. It also works as a solvent, which makes iteasier to incorporate ingredients into a day-use moisturizer. C12-15alkyl benzoate also increases spreadability by having a high surfacetension and low viscosity, solubilizes other oils and silicones, andoffers occlusion without heaviness (e.g., it is good at gettingocclusive powers of shea butter in a lighter feeling lotion). Themixture of fatty alcohols in cetearyl alcohol allows it to act as anemollient, opacifying agent and foam boosting surfactant, including as anon-aqueous viscosity-increasing agent. In this respect, cetearlyalcohol confers moisture to the skin and can also be used for purposesof emulsification. Moreover, isopropyl palmitate is a palm oil basedproduct that further acts as a moisturizer, thickening agent, andanti-static; and cyclopentasiloxane is an ingredient commonly used insilicone-based lubricants. It is preferred that the composition includeapproximately 1.0-2.0% w/w of C12-15 alkyl benzoate, 1.0-2.0% w/w ofcetearyl alcohol, 1.0-2.0% w/w of isopropyl palmitate, 1.0-2.0% w/w ofcyclopentasiloxane, 1.0-2.0% w/w of cucumis sativus (cucumber) fruitextract, and 1.0-2.0% w/w of glycol distearate. Although, each of theaforementioned emollients can be mixed and matched according to thedesired properties of the composition.

Lastly, the composition may further include between 1.0-15.0% ofbutyrospermum parkii (shea butter), dimethicone, a silicone oil toprovide skin protection, ethoxydiglycol (an alcohol used as a dryingagent), or sodium hyaluronate, a tissue lubricant.

Although several embodiments have been described in detail for purposesof illustration, various modifications may be made without departingfrom the scope and spirit of the invention. Accordingly, the inventionis not to be limited, except as by the appended claims.

What is claimed is:
 1. A pain relieving composition, consistingessentially of: a therapeutically effective amount of a numbing agentselected from the group consisting of lidocaine, prilocalne, benzocaine,and tetracaine; a therapeutically effective amount of a moisturizingagent selected from the group consisting of jojoba seed oil, palm oil,coconut oil and olive oil; a therapeutically effective amount of apenetration enhancing agent selected from the group consisting ofdimethyl sulfoxide and disodium ethylenediaminetetraacetic (EDTA); atherapeutically effective amount of a humectant selected from the groupconsisting of sorbitol, glycerine and hexylene glycol; a therapeuticallyeffective amount of an emollient selected from the group consisting ofsodium polyacrylate and caprylyl glycol; and water.